Enhertu first secured approval in 2019 for patients with high levels of HER2, a protein that promotes cancer cell growth. In 2022, the drug became the first therapy approved for H ...

Enhertu is a HER2-directed antibody and topoisomerase inhibitor conjugate. Approval of the new indication was based on data from the phase 3 DESTINY-Breast06 trial (ClinicalTrials.gov Identifier: ...

Enhertu is a HER2-directed antibody and topoisomerase inhibitor conjugate. Approval of the new indication was based on data from the phase 3 DESTINY-Breast06 trial (ClinicalTrials.gov Identifier ...

AstraZeneca AZN and partner Daiichi Sankyo announced that the FDA has approved the supplemental biologics license application (sBLA) seeking approval for expanded use of Enhertu (trastuzumab ...

The companies’ sBLA was seeking approval for Enhertu to treat unresectable or metastatic HR-positive, HER2-low or HER2-ultralow breast cancer in adult patients who have received at least one ...

AstraZeneca and Daiichi Sankyo’s antibody-drug conjugate (ADC) Enhertu (trastuzumab deruxtecan) has received approval from the US Food and Drug Administration (FDA) for an expanded indication of ...

Dr. Debu Tripathy discusses the FDA approval of Enhertu in unresectable or metastatic hormone receptor HR+, HER2-low or -ultralow breast cancer. On Jan. 27, the Food and Drug Administration (FDA) ...

Roche is the recipient of the new approval, getting the go-ahead from the US regulator for its PATHWAY HER2 (4B5) test to ...

Get Instant Summarized Text (Gist) The FDA has approved Enhertu for treating adults with unresectable or metastatic HR-positive, HER2-low, or HER2-ultralow breast cancer. This approval follows the ...

seeking approval for expanded use of Enhertu (trastuzumab deruxtecan) for HER2-low metastatic breast cancer in the United States. The approval of the added indication has triggered a $175 million ...